Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine

NCT06857370 | Active Not Recruiting Phase 3

• 1 other identifier: CTP-DTcP-003
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization according to the procedure of one dose each at 2, 4, and 6 months of age.

Conditions

Diphtheria, Tetanus and Acellular Pertussis

Keywords

Vaccine; Three Components; Immunogenicity; Safety; 2 months old

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.

  30 days after vaccination

Secondary Outcomes (6)

• Seroconversion rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine.

  30 days after vaccination

• Seropositivity rate of serum anti-PT, FHA, PRN, DT, and TT antibodies in 2-month-old subjects with three different batches of the trial vaccine

  30 days after vaccination

• Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.

  Within 30 minutes post-vaccination

• Incidence of solicited adverse reactions for each vaccine dose in 2-month-old subjects.

  Within 0-7 days

• Incidence of unsolicited adverse reactions for each vaccine dose in 2-month-old subjects.

  Within 0-30 days

Study Arms (3)

Experimental vaccine group A, 2 months old

EXPERIMENTAL

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1)

Experimental vaccine group B, 2 months old

EXPERIMENTAL

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2)

Experimental vaccine group C, 2 months old

EXPERIMENTAL

3 doses of DTcP vaccine (0.5 ml) on Day 0and Month 2,4

Biological: Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)

Interventions

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1) BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Experimental vaccine group A, 2 months old

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2) BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Experimental vaccine group B, 2 months old

Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3) BIOLOGICAL

Three doses of basic immunization were completed at 2, 4 and 6 months of age

Experimental vaccine group C, 2 months old

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months of age (60\~89 days), willing to provide identification documents;
• The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and can comply with the requirements of the clinical research protocol.

You may not qualify if:

• Persons who have received a vaccine containing the DPT classified vaccine;
• Premature labor (delivery before 37th week of gestation), low birth weight 60 (birth weight \<2500g);
• Those with abnormal labor and delivery, history of asphyxia rescue, history of neurological damage;
• Who have had one of the pertussis, diphtheria or tetanus diseases;
• Who have had household contact with an individual diagnosed with pertussis, diphtheria, or tetanus disease in the past 30 days;
• Have a history of allergy to vaccines or vaccine components and severe side reactions to vaccines, such as hives, dyspnea, angioneurotic edema, and other allergic reactions;
• Persons with a history of seizures, convulsions, convulsions, or cerebral palsy; or a history or family history of psychiatric illness; or other progressive neurologic disorders;
• Have been diagnosed with an immunodeficiency, Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic Lupus Erythematosus (SLE), Juvenile Rheumatoid Arthritis ( Juvenile Rheumatoid Arthritis (JRA) or other autoimmune diseases;
• Any condition resulting in absence of spleen, defective spleen function;
• Known or suspected acute illness or severe chronic disease (including: severe respiratory disease, severe cardiovascular disease, liver or kidney disease, severe skin disease, malignancy, etc.); or in an acute exacerbation of a chronic disease;
• Physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders;
• Immunosuppressive or modifying agents, cytotoxic consecutive therapy for more than 10 days (except inhaled and topical steroids) within 2 months prior to receiving the test vaccine;
• Received blood products (other than hepatitis B immune globulin) within 2 months prior to receiving the test vaccine;
• Participated or planning to participate in any other drug or vaccine clinical study;
• Has received an injectable live attenuated vaccine within 14 days or another vaccine within 7 days prior to receiving the test vaccine;

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Changge Center for Disease Control and Prevention

Xuchang, Henan, 461500, China

Location

MeSH Terms

Conditions

Diphtheria; Tetanus

Interventions

Tetanus Toxoid; Vaccines, Combined

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yanxia Wang

  Henan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 23, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-02

Locations

CN (1)